title: Drug-eluting balloon in peripheral intervention for below the knee angioplasty evaluation (DEBATE-BTK): a randomized trial in diabetic patients with critical limb ischemia.
abstract: BACKGROUND
  The 1-year restenosis rate after balloon angioplasty of long lesions in below-the-knee arteries may be as high as 70%. Our aim was to investigate the efficacy of a paclitaxel drug-eluting balloons versus conventional percutaneous transluminal angioplasty (PTA) for the reduction of restenosis in diabetic patients with critical limb ischemia undergoing endovascular intervention of below-the-knee arteries.
  
  
  RESULTS
  The Drug-Eluting Balloon in Peripheral Intervention for below the knee angioplasty evaluation (DEBATE-BTK) is a randomized, open-label, single-center study comparing drug-eluting balloons and PTA. Inclusion criteria were diabetes mellitus, critical limb ischemia (Rutherford class 4 or higher), significant stenosis or occlusion >40 mm of at least 1 below-the-knee vessel with distal runoff, and life expectancy >1 year. Binary in-segment restenosis at a 1-year angiographic or ultrasonographic follow-up was the primary end point. Clinically driven target lesion revascularization, major amputation, and target vessel occlusion were the secondary end points. One hundred thirty-two patients with 158 infrapopliteal atherosclerotic lesions were enrolled. Mean length of the treated segments was 129±83 mm in the drug-eluting balloon group compared with 131±79 mm in the PTA group (P=0.7). Binary restenosis, assessed by angiography in >90% of patients, occurred in 20 of 74 lesions (27%) in the drug-eluting balloon group compared with 55 of 74 lesions (74%) in the PTA group (P<0.001); target lesion revascularization, in 12 (18%) versus 29 (43%; P=0.002); and target vessel occlusion, in 12 (17%) versus 41 (55%; P<0.001). Only 1 major amputation occurred, in the PTA group (P=0.9).
  
  
  CONCLUSIONS
  Drug-eluting balloons compared with PTA strikingly reduce 1-year restenosis, target lesion revascularization, and target vessel occlusion in the treatment of below-the-knee lesions in diabetic patients with critical limb ischemia.
authors.affiliation: Cardiovascular and Neurological Department, San Donato Hospital, Via Pietro Nenni 20, 52100, Arezzo, Italy. francescoliistro@hotmail.com
authors.forename: Francesco
authors.initials: F
authors.lastname: Liistro
authors.forename: Italo
authors.initials: I
authors.lastname: Porto
authors.forename: Paolo
authors.initials: P
authors.lastname: Angioli
authors.forename: Simone
authors.initials: S
authors.lastname: Grotti
authors.forename: Lucia
authors.initials: L
authors.lastname: Ricci
authors.forename: Kenneth
authors.initials: K
authors.lastname: Ducci
authors.forename: Giovanni
authors.initials: G
authors.lastname: Falsini
authors.forename: Giorgio
authors.initials: G
authors.lastname: Ventoruzzo
authors.forename: Filippo
authors.initials: F
authors.lastname: Turini
authors.forename: Guido
authors.initials: G
authors.lastname: Bellandi
authors.forename: Leonardo
authors.initials: L
authors.lastname: Bolognese
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000800:Angioplasty, Balloon / Q000295:instrumentation / Q000379:methods*; D003925:Diabetic Angiopathies / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007511:Ischemia / Q000628:therapy*; D007717:Knee; D007866:Leg / Q000098:blood supply*; D023821:Limb Salvage / Q000379:methods; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D011446:Prospective Studies; D055502:Secondary Prevention; D016896:Treatment Outcome; D050257:Tubulin Modulators / Q000008:administration & dosage
chemical_list: D050257:Tubulin Modulators; D017239:Paclitaxel